Clinical Decision Support SystemNCT07623304
Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures
A study testing Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Basic Postoperative Care and Conventional Postoperative Care in people with Clinical Decision Support System, run by Jiawei Jiang at 1 site in China.
Trial summary
This study aims to develop a clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, based on evidence-based recommendations for postoperative exercise rehabilitation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clinical Decision Support System
- What is being tested?
- Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Basic Postoperative Care and Conventional Postoperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 55 years
- diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
- Surgical procedures performed by the same surgical team
- willingness to comply with the study protocol and restrictions
- availability of a home WiFi connection
Who cannot join
- lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
- postoperative infection or revision surgery
- presence of cauda equina syndrome
- diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
- coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Affiliated 2 Hospital of Nantong University, Nantong, Jiangsu 0513
Nantong, Jiangsu
Hong Gao, 13773643315, 2439220393@qq.com
Hongqing Xu, Dr
About this study
This study aims to develop a clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, based on evidence-based recommendations for postoperative exercise rehabilitation. The system is designed to provide individualized assessment and exercise interventions, monitor exercise behaviors, and deliver risk alerts, thereby promoting safe and standardized postoperative exercise training in OVCF patients. The ultimate objectives are to evaluate the feasibility and effectiveness of the system in increasing physical exercise participation, reducing sedentary time, and facilitating postoperative rehabilitation, without increasing fatigue or pain.
- Conditions
- Clinical Decision Support System
- Being tested
- Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Basic Postoperative Care, Conventional Postoperative Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fracturesBehavioural
The experimental group first developed the functional modules of the OVCF exercise rehabilitation decision support system. Researchers were trained on participant selection, module use, and task allocation. Participants received operation demonstrations and a QR code for video guidance, then registered accounts and entered data. The system auto-captured baseline indicators, generated individualized exercise prescriptions, and pushed them for staff approval. Before and after each exercise session, patients completed vital signs, pain, and fatigue assessments; the system analyzed these data, generated decision support, and recommended next steps for therapist review. Data management included visualization, click tracking, and identification of low compliance, triggering individual online support. A user group facilitated communication. At follow-ups, osteoporosis clinic staff reviewed personal information and adjusted prescriptions based on exercise experience and outcomes.
Basic Postoperative CareBehavioural
All participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period.
Conventional Postoperative CareBehavioural
Before discharge, patients received exercise rehabilitation training guidance from orthopedic specialist nurses and rehabilitation therapists and were given a rehabilitation training manual. They were instructed to scan the QR code in the manual to watch exercise training videos. The manual contained information including the goals, methods, frequency, intensity, and precautions of the exercise training.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group | Experimental | The experimental group received individualized assessment and exercise rehabilitation intervention through the clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures. Receives: Behavioral: Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures; Behavioral: Basic Postoperative Care |
| The control group | Active comparator | The control group received conventional postoperative care interventions Receives: Behavioral: Basic Postoperative Care; Behavioral: Conventional Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPAQ-L Scores
Physical activity levels were assessed using the Chinese version of the International Physical Activity Questionnaire-Long (IPAQ-L) adapted by Qu Ningning et al. The questionnaire comprises 27 items across six domains: work, transportation, domestic activities, exercise and recreation, sitting time, and sleep time. Each domain includes physical activities at high, moderate, and low intensities. Based on the number of days and accumulated time per day of activity in the past week, weekly physical activity energy expenditure was calculated and expressed in metabolic equivalents (METs). The test-retest reliability (r=0.927) and criterion validity (r=0.821) of this questionnaire are higher than or equal to those of comparable instruments.
Measured: The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.
Secondary outcomes (3)
RPE Score
Fatigue was assessed using the Borg Rating of Perceived Exertion (RPE) , a subjective tool for evaluating exercise intensity developed by Swedish psychologist Gunnar Borg, designed to quantify an individual's perception of physical exertion during exercise. On the scale, 6 represents no exertion at all; 7-8 indicates extremely light exertion (e.g.sitting quietly); 9-10, very light; 11-12, light exertion; 13-14, moderate exertion; 15-16, heavy exertion; 17-18, very heavy exertion; and 19-20, extremely exhausting, approaching maximal exertion.
Measured: The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.
NRS Score
Postoperative pain was assessed using the Numerical Rating Scale (NRS), with a total score ranging from 0 to 10, where 0 indicates no pain, 1-3 indicates mild pain, 4-6 indicates moderate pain, 7-9 indicates severe pain, and 10 indicates excruciating pain.
Measured: The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.
SUS Score
Usability was evaluated using the System Usability Scale (SUS) [15-16], which consists of 10 items rated on a 5-point Likert scale, with 1 representing "strongly disagree" and 5 representing "strongly agree." For odd-numbered items, the item score is the response score minus 1; for even-numbered items, the item score is 5 minus the response score. If an item is left blank, it is assigned a score of 3. The sum of the 10 item scores is multiplied by 2.5 to yield the final SUS score, which ranges from 0 to 100. A score above 60 indicates acceptable usability, ≥70 indicates good usability, ≥80 indicates very good usability, and ≥90 indicates excellent usability. The Cronbach's α coefficient of the scale was 0.91.
Measured: The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision Support SystemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiawei Jiang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiawei Jiang, Affiliated 2 Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623304
- Sponsor's protocol ID
- HGao
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Clinical Decision Support System for Exercise Rehabilitation in Patients With Osteoporotic Vertebral Compression Fractures
- ClinicalTrials.gov ID
- NCT07623304
- Acronym / sponsor ID
- HGao
- Conditions
- Clinical Decision Support System
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiawei JiangUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to develop a clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, based on evidence-based recommendations for postoperative exercise rehabilitation. The system is designed to provide individualized assessment and exercise interventions, monitor exercise behaviors, and deliver risk alerts, thereby promoting safe and standardized postoperative exercise training in OVCF patients. The ultimate objectives are to evaluate the feasibility and effectiveness of the system in increasing physical exercise participation, reducing sedentary time, and facilitating postoperative rehabilitation, without increasing fatigue or pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Experimental | Behavioral: Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Behavioral: Basic Postoperative CareThe experimental group received individualized assessment and exercise rehabilitation intervention through the clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures. |
| The control group | Active comparator | Behavioral: Basic Postoperative Care, Behavioral: Conventional Postoperative CareThe control group received conventional postoperative care interventions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 55 years
- diagnosis of lumbar disc herniation requiring single-level lumbar fusion surgery - no previous history of lumbar surgery
- Surgical procedures performed by the same surgical team
- willingness to comply with the study protocol and restrictions
- availability of a home WiFi connection
Key exclusion criteria (5 listed)
- lumbar surgery secondary to neoplasm, tuberculosis, infection, or inflammation
- postoperative infection or revision surgery
- presence of cauda equina syndrome
- diagnosis of schizophrenia, cognitive impairment, or other psychiatric disorders
- coexisting severe cardiovascular or cerebrovascular diseases, or congenital conditions precluding exercise participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fracturesThe experimental group first developed the functional modules of the OVCF exercise rehabilitation decision support system. Researchers were trained on participant selection, module use, and task allocation. Participants received operation demonstrations and a QR code for video guidance, then registered accounts and entered data. The system auto-captured baseline indicators, generated individualized exercise prescriptions, and pushed them for staff approval. Before and after each exercise session, patients completed vital signs, pain, and fatigue assessments; the system analyzed these data, generated decision support, and recommended next steps for therapist review. Data management included visualization, click tracking, and identification of low compliance, triggering individual online support. A user group facilitated communication. At follow-ups, osteoporosis clinic staff reviewed personal information and adjusted prescriptions based on exercise experience and outcomes. | Behavioural | The intervention group |
| Basic Postoperative CareAll participants were instructed to maintain their usual daily activities and abstain from additional treatments throughout the 6-month study period. | Behavioural | The control group, The intervention group |
| Conventional Postoperative CareBefore discharge, patients received exercise rehabilitation training guidance from orthopedic specialist nurses and rehabilitation therapists and were given a rehabilitation training manual. They were instructed to scan the QR code in the manual to watch exercise training videos. The manual contained information including the goals, methods, frequency, intensity, and precautions of the exercise training. | Behavioural | The control group |
Primary outcome
IPAQ-L Scores
Time frame: The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.
Physical activity levels were assessed using the Chinese version of the International Physical Activity Questionnaire-Long (IPAQ-L) adapted by Qu Ningning et al. The questionnaire comprises 27 items across six domains: work, transportation, domestic activities, exercise and recreation, sitting time, and sleep time. Each domain includes physical activities at high, moderate, and low intensities. Based on the number of days and accumulated time per day of activity in the past week, weekly physical activity energy expenditure was calculated and expressed in metabolic equivalents (METs). The test-retest reliability (r=0.927) and criterion validity (r=0.821) of this questionnaire are higher than or equal to those of comparable instruments.
3 secondary outcomes
RPE Score
Time frame: The RPE scores were collected at baseline and at 3 months, and 6 months post-intervention.
NRS Score
Time frame: The NRS scores were collected at baseline and at 3 months, and 6 months post-intervention.
SUS Score
Time frame: The SUS scores were collected at baseline and at 3 months, and 6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Support System: A clinical decision support system for exercise rehabilitation in patients with osteoporotic vertebral compression fractures, Basic Postoperative Care and Conventional Postoperative Care in people with Clinical Decision Support System, run by Jiawei Jiang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong GAO (13773643315, 2439220393@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPAQ-L Scores (time frame: The IPAQ-L scores were collected at baseline and at 3 months, and 6 months post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.